A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement of Neurologic, Cognitive Function and Quality of Life

This study is to randomize stroke patients either to the SSRI, Lexacure tablet or placebo and to investigate whether Lexacure is effective in preventing depression and related symptoms at 3 months after the drug administration.

Patients with acute stroke (within 21 days after onset) will be enrolled and take the study drug 5mg during the first week and then 10mg (from the 2nd week) until 12 weeks.

The first visit should be performed at 4 weeks after drug administration. Drug safety, depression and related symptoms will be evaluated and the following 12-week visit will be performed. In the 13th week after the drug administration, the study drug will be reduced to 10mg every other day for one week, and the schedule of drug administration will be completed.

At the 14th week, all subjects will be instructed not to take the study drug for assessing maintenance effect. At the 24th week, subjects will have follow-up visits to assess poststroke depression and related symptoms.

If a subject discontinues the study before termination for severe depression, aggressive intervention will be initiated at the 4th week, and the 12-week visit will be performed unless the subject disagrees. If investigators judge the patients have severe depression at the 12-week visit, they should be treated. All the patients who need to treat depression will be followed until 12th week.

Eligibility

Ages Eligible for Study:

20 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adults older than 20 years

Patients with acute stroke (ischemic stroke or cerebral hemorrhage) confirmed by neuroimaging within 21 days after stroke onset

Patients with hemorrhagic transformation of infarcted tissue will not be included, but if investigators judge the risk of bleeding is small (i.e., reduced amount of blood in follow-up neuroimaging) those patients can be enrolled.

Patients with MRS ≥ 2 on screening

Patients without definite history of depression

Patients who fulfill the following criteria in the K-MADRS test:

The combined score of the 9th question (pessimistic thoughts) and the 10th question (suicidal idea) ≤ 7 The score of the 10th question < 6

Patients without serious communication problem

Patients who agree to participate in this trial

Exclusion Criteria:

Patients with MRS 0 or 1 on screening

Patients who have definite history of depression or have taken antidepressants

Patients who have been diagnosed as having bipolar disorder or other psychiatric disorders

Patients with severe dementia or aphasia. However, those who have motor aphasia but are still communicable can be enrolled

Patients who have taken migraine medication on screening or those who are expected to take migraine medication frequently due to severe migraine

Patients who have strong suicidal idea on screening test or those who express their wish to be treated for depression

Patients who are considered to be treated for depression by charged physicians

Patients who need SSRI medication for other reasons

Patients who have taken antiepileptic drugs on screening

Patients who have a history of traumatic brain injury, brain tumor, or other brain disease (except stroke) within 30 days prior to screening

Patients who are participating in another clinical trial, but those who are participating in the observational study can be enrolled

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278498